Giving Consent without Getting Informed: A Cross-Cultural Issue in Research Ethics

Ghandour, Lilian; Yasmine, Rola; El-Kak, Faysal

doi:10.1525/jer.2013.8.3.12

Cited by 19 publications

(8 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Clearly, to adequately inform prospective participants, consent forms must be readable and comprehensive. Nevertheless, studies have reported that research participants often lack knowledge and understanding regarding the nature of the research in which they are enrolled, for example, not knowing the purpose or risks of the study or not understanding the concept of randomization (Cahana & Hurst, 2008; Falagas, Korbila, Giannopoulou, Kondilis, & Peppas, 2009; Ghandour, Yasmine, & El-Kak, 2013). This can result in therapeutic misconception, that is, the participant believes that they have volunteered for treatment that will benefit them rather than for research.…”

mentioning

confidence: 99%

Reading Level and Comprehension of Research Consent Forms

Foe

Larson

2016

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

Consent forms continue to be at a higher reading level than the recommended sixth to eighth grade, making it difficult for participants to comprehend information before enrolling in research. To assess and address the extent of the problem regarding the level of literacy of consent forms and update previously published reports, we conducted an integrative literature review of English language research published between January 1, 2000, and December 31, 2013; 35 descriptive and eight intervention studies met inclusion criteria. Results confirmed that developing forms at eighth-grade level was attainable though not practiced. It was found that risks of participation was the section most poorly understood. There was also a lack of consensus regarding the most effective method to increase comprehension. Further research using standardized tools is needed to determine the best approach for improving consent forms and processes.

show abstract

mentioning

confidence: 99%

Reading Level and Comprehension of Research Consent Forms

Foe

Larson

2016

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

show abstract

“…These findings are consistent with the findings of a study that quantified the amount of time (overall, not by section) spent by 2,534 Lebanese college students reading an online consent form for research on students’ sexuality and sexual practices. The median time subjects took to “read” an 815-word consent form was 18.66 s, as opposed to the minimum predicted time of 2.7 min (Ghandour et al., 2013).…”

Section: Discussionmentioning

confidence: 98%

“…Previously reported barriers to participation have included high reading levels, excessive medical jargon and low attention to the specific needs of this inherently vulnerable population (Flory & Emanuel, 2004; Schreiner, 2013; Sugarman & Paasche-Orlow, 2006; Tait, Voepel-Lewis, Malviya, & Philipson, 2005). Other evidence suggests that people prefer trusting the researcher to spending time reading a consent form (e.g., Ghandour, Yasmine, & El-Kak, 2013). The purpose of this study was to assess the self-reported reading and understanding of informed consent documents in a Phase 1 clinical trial among a sample of adults with low incomes.…”

mentioning

confidence: 99%

Readability and Understanding of Informed Consent Among Participants With Low Incomes

Ittenbach

Senft

Huang

et al. 2015

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices.

show abstract

“…Clinicians have raised the alarm that the consent process is “broken” (Hayden, 2012). For example, research has shown that patients have great difficulty understanding and recounting the research to which they have consented (Brehaut et al, 2012; Ghandour, Yasmine, & El-Kak, 2013; Lee, Lampert, Wilder, & Sowell, 2011; Tamariz, Palacio, Robert, & Marcus, 2013). In other words, clinicians are concerned that the informed consent process leaves research participants and patients not informed about how their data will be used.…”

Section: Introductionmentioning

confidence: 99%

Did I Tell You That? Ethical Issues Related to Using Computational Methods to Discover Non-Disclosed Patient Characteristics

Cato

Bockting

Larson

2016

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

Background Widespread availability of large data sets through warehousing of electronic health records coupled with increasingly sophisticated information technology and related statistical methods offer great potential for a variety of applications for health and disease surveillance, developing predictive models and advancing decision support for clinicians. However, use of such ‘big data’ mining and discovery techniques has also raised ethical issues such as how to balance privacy and autonomy with the wider public benefits of data sharing. More specifically, electronic data are being increasingly used to identify individual characteristics which can be useful for clinical prediction and management, but that were not previously disclosed to a clinician. This process in computer parlance is called electronic phenotyping, and has a number of ethical implications. Approach Using the Belmont Report’s principles of respect for persons, beneficence, and justice as a framework, we examined the ethical issues posed by electronic phenotyping. Findings Ethical issues identified include the ability of the patient to consent for the use of their information, the ability to suppress pediatric information, ensuring that the potential benefits justify the risks of harm to patients, and acknowledging that the clinician’s biases or stereotypes, conscious or unintended, may also become a factor in the therapeutic interaction. We illustrate these issues with two vignettes, using the person characteristic of gender minority status (i.e., transgender identity) and the health history characteristic of substance abuse. Conclusion Big data mining has the potential to uncover patient characteristics previously obscured which can provide clinicians with beneficial clinical information. Hence, ethical guidelines must be updated to ensure that electronic phenotyping supports the principles of respect for persons, beneficence, and justice.

show abstract

Giving Consent without Getting Informed: A Cross-Cultural Issue in Research Ethics

Cited by 19 publications

References 14 publications

Reading Level and Comprehension of Research Consent Forms

Reading Level and Comprehension of Research Consent Forms

Readability and Understanding of Informed Consent Among Participants With Low Incomes

Did I Tell You That? Ethical Issues Related to Using Computational Methods to Discover Non-Disclosed Patient Characteristics

Contact Info

Product

Resources

About